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| ID | Type | Description | Link |
|---|---|---|---|
| 24-005929 | Other Identifier | Mayo Clinic |
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This observational study is to better understand how children and their families recover after the stress of major surgery for cancer so that investigators can create ways to improve resilience during recovery. The main questions it aims to answer are:
Participants, including pediatric patients undergoing surgery for cancer and their primary caregiver, will be asked to:
These actions will occur at baseline prior to patients' surgery and then afterwards for up to one year. There are no changes to participants' clinical care or surgical care as a result of the study. Investigators will also collect participants' clinical information and cancer-specific outcomes. Participants will be remunerated for their time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Children and young adults 3-18 years old who are undergoing surgical resection of an extracranial solid tumor. |
| |
| Caregiver | Primary caregiver or parent of a a child or young adults 3-18 years old who is undergoing surgical resection for an extracranial solid tumor and has agreed to participate in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearing Smartwatch | Other | Patients and their caregivers will be asked to start wearing a smartwatch prior to surgery and continuing to wear it for one year following surgery at all times except when bathing or swimming, eating, undergoing a procedure, or if refusing to wear them. The smartwatches collect motor activity by minutes spent being sedentary, active, or highly active, heart rate, and sleep duration and stages. Data from the smartwatches syncs with Garmin connect using Fitabase to allow the study team to review the data. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical resilience | Using smartwatches, we will assess motor activity by minutes spent being sedentary, active, or highly active, heart rate, and sleep duration and stages. This information will be collected before and after surgical resection. Data from the smartwatches syncs with Garmin connect using Fitabase which allows the study team to monitor and analyze the data. Results will be correlated with questionnaires responses, to see if there are digital biomarker patterns associated with return to baseline quality of life postoperatively. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life - PedsQL | Results from Pediatric Quality of Life Inventory (PedsQL) Brain Tumor Module will be used to evaluate the quality of life outcomes in patients up to 18 years old. PedsQL™ assessments include 23 items answered on a Likert scale where 0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem. | 1 year |
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Inclusion Criteria:
-OR-
Exclusion Criteria:
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Children and young adults 3-18 years old who are undergoing surgical resection for an extracranial solid tumor and their primary caregiver or guardian.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mayo Clinic Pediatric Surgery Clinical Research Unit | Contact | 507-266-4467 | DOSCRO2@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Polites, M.D., M.P.H. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55901 | United States |
Investigators do not plan to share IPD to protect participants' confidentiality.
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Blood samples will be used for future proteomic, metabolomic, and exposomic testing.
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| Patient Report Outcomes | Other | To obtain patient-reported outcomes (PROs), questionnaires will be administered at time of enrollment, in the two weeks prior to surgery if applicable, and at 1, 2, 4, 8, 12, 16, 20, 24, 34, 44, and 54 weeks postoperatively. Questionnaires can be completed electronically, over the telephone or in person. The PedsQL Cancer Module and Patient Health Questionnaire depression scale (PHQ-9) will be utilized for questionnaires. |
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| Blood Draw | Other | When patients are having blood drawn as part of their regular care, extra blood may be drawn for this study. Participants may opt out of this. Blood draws will occur preoperatively and at intervals postoperatively for proteomic, metabolomic, and exposomic testing. |
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| Clinical Data Review | Other | Clinical data will be collected and stored in a database by study staff. This includes patient demographics, diagnosis characteristics including staging and risk group, treatment characteristics, and outcomes including length of stay following surgical intervention, readmissions, surgical complications including surgical site infection, time off therapy/time to resumption of chemotherapy. |
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| Quality of life - PHQ-9 | The Patient Health Questionnaire (PHQ)-9 consists of 9 items related to problems over the last 2 weeks. Items are answered on a 4-point Likert scale where 0=not at all; 1=several days, 2=more than half the days; and 3=nearly every day. If any problem items were indicated, participants are asked to answer a final question with one of the following: not difficult at all; somewhat difficult; very difficult; or extremely difficult. | 1 year |
| Biomarkers | Participants who are the patients having surgery will have extra blood collected during routine clinical blood draws over time. This will be used for proteomic, metabolomic, and exposomic testing to see if specific proteins, metabolites, or chemicals are changed from baseline after surgery and if any levels are associated with improved resilience or quality of life. | 1 year |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009447 | Neuroblastoma |
| D012509 | Sarcoma |
| D009396 | Wilms Tumor |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D018193 | Neoplasms, Complex and Mixed |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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